ICE-SENSE


Device Classification Name

unit, cryosurgical, accessories

510(k) Number K072883
Device Name ICE-SENSE
Applicant
ARBEL MEDICAL LTD.
990 washington st.
dedham, 
MA 
02026

Applicant Contact zvi ladin
Correspondent
ARBEL MEDICAL LTD.
990 washington st.
dedham, 
MA 
02026

Correspodent Contact zvi ladin
Regulation Number 878.4350
Classification Product Code
GEH  
Date Received 10/09/2007
Decision Date 12/10/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No